By: Dr Irina Webster
Bulimia Nervosa is a long term disease. Recovery is often a hard and a long process with its ups and downs. That is why bulimia nervosa testimonials of recovery are interesting to read. You can always learn something interesting about how other people managed to beat this distorting body and sole disease. There are always a few very interesting stories about this.I will tell you mine… I always say that my story is not that bad as some others, who have developed an eating disorder, but I can tell you for a child as I was at the time, it was very traumatic. You see I was forced to study for hours after school with no contacts outside the house, during school days and on most weekends. Her friends soon learned not to call her or drop around after school or on the weekends as they would be chased away. As we know today children need recreation to develop skills and they get these from playing with other children so I was at a disadvantage. I soon developed bad eating habits as a kind of escape mechanism; it was more like binge eating (I ate just to make myself feel better, not because I was hungry). Soon my mother started to tell me I was getting big and I should stop eating so much. I don't believe I was getting bigger it was simply a matter that when I was 13, I was more developed than most of my piers. The problem was that I could not stop eating, as it had become the escape I needed to handle my situation. But because of the pressure I was under I soon worked out that I could eat heaps as long as I purged it up. This simply became a way of life for me and my bulimia was born.But don't get me wrong, I do not blame my parents as they thought they were doing the best for me and making sure I had the top grades that I needed to get into university as I had always wanted to be a doctor and help people. I think my parents were proud of the fact their daughter was an A grade student, it was prestigious to be so in the place I grow up in. I won all the regional schools events, like best science student, best Math student, regional champion etc. While other kids were doing their stuff on the sporting field, I was tied to my books: virtually 7 days a week.Did it deprive me of a childhood? Sure it did. But am I angry now? No, I am not because in away it has given me an insight into how eating disorders can get a hold of you and change you into somebody else. It was only when I realized through my studies at medical school that I was doing a lot of harm to myself so I decided to seek help.I started to approach my lecturers as I thought that they would know exactly what I should do to get rid of my problems: but it soon became apparent to me that the only help they could provide was to send me to counselors.You see when you are young and impressionable you tend to believe people in higher positions like I thought my lecturers were. I thought they would know all about things, after all they were doctors and they were teaching me all about medicine: but they didn’t. I struggled through the normal round of therapists, councilors and visiting the clinics. I did feel better when I was talking to them but slipped back to my old eating habits when I was at home.It also became apparent to me after awhile that I was not getting any real help from them either; I decided that the only person who could help me was me. But deep inside I thought if I stopped my bulimia how would I get through the day and cope with everyday stresses, I was actually scared to let it go. By this time the bulimia had become a habit and so addictive, being without it was incomprehensible to me. I often think now, how other sufferers must feel? After all I was being trained as a doctor, so I had a little bit more knowledge about how the body works than the average person and here I was trapped by this terrible affliction: what must they be going through? But you see I knew nothing about the real implications of emotions or emotional blockages and the role they play in an eating disorder. Sure I knew that my problem was emotional in nature: but not one of the specialists, councilors or my lecturers really knew how to remove these emotional blockages and they knew absolutely nothing about emotional strengthening: that in the end became the way I managed to recover. It was here that I found real help and soon started to formulate alternative methods for myself and finally I came up with a system that worked for me and I was finally free from my affliction. Now, I understand that it does not matter how much you as a sufferer want to stop your eating disorder: unless you can break the mental conditioning and the mental blockages you will always fail: no exceptions.Here is why: When it comes to getting results, your self-belief (programming) will always win out over your conscious desire.Why is this, why does this always happen? It happens because the mental blockages from the past are still there controlling your every move. It is those little voices that keep telling you:” You should go on binge.” These are the same voices I had that told me I could not get through the stresses of the day without my bulimia. To sum up, all bulimia nervosa testimonials of recovery are probably different. And it all depends on a personal story of individual. But the common thing of all successful bulimia nervosa testimonials is that there is some kind of special methodology we followed to beat this condition. And my methodology was identifying and removing subconscious blockages I had from the past.To read about the methodology go www.bulimia-cure.com
Friday, 21 September 2007
Aquasize To A Flatter Abdominals!
By: Li Ming Wong
When the weather is warm, there is nothing quite like going for a refreshing swim at the local pool. To add to the benefits, you can use it as an opportunity to work on those abdominal muscles. The water provides natural resistance, making the pool a great place to do abdominal exercises to flatten out that tummy. Despite the greater resistance water has than air, aquasizing is low-impact, meaning less strain on joints. Try out these exercises next time you take a trip down to your pool. Remember, consult your doctor before beginning a new workout routine, and always warm up properly to prevent injury. The first set of exercises to try is called the jump and dig. There are two moves in this set, one for the upper body and one for the lower body. The former is great for your obliques, and the latter works on your abdominals. To start, stand in water that is between your belly button and chest. To work the lower body (including your abdominals), put your feet a wide distance apart, then jump so your knees come up to the surface of the water and back down. Picture a frog as you do it; this will help you get the form right. Next, to work the upper body, begin by making a scoop with both hands at the surface of the water. Bring your hand scoop below the surface, then scoop up and to one side. Alternate sides to work the obliques on both sides. Start by doing the two moves separately for three minutes each. Once you have mastered the form, do them at the same time to exercise both sets of abdominal muscles at once. As you build strength and endurance, you can add water gloves to increase resistance. You can also do the exercises faster, packing more reps into each three minute period. Form is key, though. Do not sacrifice form for the sake of speed. It is better to do it properly than quickly. Also remember to set fitness goals and work toward them at a gradual pace. Do not push yourself too hard, too fast. You may want to see results fast, but an injury will seriously delay your workout goals. Start small, know your limits, and build gradually. As long as you are working on your midsection, here are a few additional tips. First, proper diet is essential to any fitness routine. A great, hard workout can be completely negated by improper eating habits. Second, stay hydrated both while working out and in everyday life. A good rule of thumb is to take your body weight in pounds, divide it by 2, and drink that number of ounces of water each day. This helps to keep the body functioning at it's highest level. Third, rest up. This means not only getting plenty of sleep, but also getting the right kind of sleep. Spend all night sleeping on your abdominal, and you will wake up with a sore back, making it difficult to do your abdominal exercises. Also be sure to schedule off days into your routine to give your muscles a chance to rest up and rebuild. Now you already have a great start on a toned, flat abdominal!
When the weather is warm, there is nothing quite like going for a refreshing swim at the local pool. To add to the benefits, you can use it as an opportunity to work on those abdominal muscles. The water provides natural resistance, making the pool a great place to do abdominal exercises to flatten out that tummy. Despite the greater resistance water has than air, aquasizing is low-impact, meaning less strain on joints. Try out these exercises next time you take a trip down to your pool. Remember, consult your doctor before beginning a new workout routine, and always warm up properly to prevent injury. The first set of exercises to try is called the jump and dig. There are two moves in this set, one for the upper body and one for the lower body. The former is great for your obliques, and the latter works on your abdominals. To start, stand in water that is between your belly button and chest. To work the lower body (including your abdominals), put your feet a wide distance apart, then jump so your knees come up to the surface of the water and back down. Picture a frog as you do it; this will help you get the form right. Next, to work the upper body, begin by making a scoop with both hands at the surface of the water. Bring your hand scoop below the surface, then scoop up and to one side. Alternate sides to work the obliques on both sides. Start by doing the two moves separately for three minutes each. Once you have mastered the form, do them at the same time to exercise both sets of abdominal muscles at once. As you build strength and endurance, you can add water gloves to increase resistance. You can also do the exercises faster, packing more reps into each three minute period. Form is key, though. Do not sacrifice form for the sake of speed. It is better to do it properly than quickly. Also remember to set fitness goals and work toward them at a gradual pace. Do not push yourself too hard, too fast. You may want to see results fast, but an injury will seriously delay your workout goals. Start small, know your limits, and build gradually. As long as you are working on your midsection, here are a few additional tips. First, proper diet is essential to any fitness routine. A great, hard workout can be completely negated by improper eating habits. Second, stay hydrated both while working out and in everyday life. A good rule of thumb is to take your body weight in pounds, divide it by 2, and drink that number of ounces of water each day. This helps to keep the body functioning at it's highest level. Third, rest up. This means not only getting plenty of sleep, but also getting the right kind of sleep. Spend all night sleeping on your abdominal, and you will wake up with a sore back, making it difficult to do your abdominal exercises. Also be sure to schedule off days into your routine to give your muscles a chance to rest up and rebuild. Now you already have a great start on a toned, flat abdominal!
The Benefits Of Wearing Perfume
By: Roberto Sedycias
Perfume has been used throughout history for a variety of reasons. Perfume has proved itself to be a valuable commodity in both ancient and modern times, with the modern perfume industry turnover in its billions every year. Perfume is a luxury, rather than a necessity, and yet its popularity grows rather than wavers every year. The reason behind this is the enjoyment that the wearer gains, and this type of enjoyment stems from the recognised and unnoticed benefits that wearing perfume provides. Firstly, the effect of perfume on our brains is not necessarily recognised though the effects are certainly enjoyed. Each scent, whether natural or synthetic, emits molecules which enter the nasal passages and eventually reach the olfactory epithelium. This part of the nose has a vast amount of receptor neurons which are each covered in hairs called cilia. These cilia trap the scent and send a message to the brain which enables a person to recognise the perfume. The ability to smell immediately has a positive impact. This is important as some research has shown that people without a sense of smell have a less happy life than those who can smell; scents trigger emotions and affect our mood. As a result of this finding, perfume has become as much a science as it has an accessory. Aromatherapy studies the effects of natural botanical perfume ingredients, usually in the form of oils in their purest state. Its looks at the effects upon mood and general well being, and applies the knowledge by improving the perfume in the environment and offering a variety of aromatherapy services aimed at improving people`s lives. Aromacology applies this same approach to any available scent, from flowers to sand, and the findings are currently assisting perfume manufacturers worldwide. The ingredients used in perfume may improve your concentration and enhance your mood. There is a long list of scents that are said to trigger this stimulating effect. Perfumes that contain ingredients such as ginger, sandalwood and rose are claimed by aromatherapists and aromacologists alike to have a stimulating effect on brain neurons. The increased stimulation aided by the use of perfume assists in many everyday tasks, from more focused studying to extra stamina and energy, balanced weight loss to an improved immune system. Another benefit to be gained from wearing perfume is that it can relax your mood. Certain scents have aldehydes which have a calming effect on the brain. The perfume oils which have this effect include eucalyptus and citronella. Other scents can act as a form of sedative, aiding restful sleep, which helps reduce anxiety and tension which in turn creates a wealth of health benefits. The most famous of these perfumes include lavender and bergamot, which have been used for this purpose for centuries and in a variety of countries worldwide. The benefits of perfume are not just highlighted by scientific study. Many psychologists state that humans begin to store information about scents when only a few months old, and that scents affect reactions to people and events more than any of the other senses at this young age. In fact, our taste in smells remains more or less the same whereas tastes influenced by other senses are extremely changeable. This means that we choose perfumes for a reason, either it triggers a feeling of nostalgia or makes us feel a certain way. The perfume chosen also has a social relevance; it tells people something about the wearer, and helps cement their identity. Attraction to another person is influenced by invisible scents known as pheromones, and perfume adds to this. Above all, perfume makes the wearer feel fresh, attractive and more confident; and confidence is a definite benefit. This article is under GNU FDL license and can be distributed without any previous authorization from the author. However the author's name and all the URLs (links) mentioned in the article and biography must be kept.
Perfume has been used throughout history for a variety of reasons. Perfume has proved itself to be a valuable commodity in both ancient and modern times, with the modern perfume industry turnover in its billions every year. Perfume is a luxury, rather than a necessity, and yet its popularity grows rather than wavers every year. The reason behind this is the enjoyment that the wearer gains, and this type of enjoyment stems from the recognised and unnoticed benefits that wearing perfume provides. Firstly, the effect of perfume on our brains is not necessarily recognised though the effects are certainly enjoyed. Each scent, whether natural or synthetic, emits molecules which enter the nasal passages and eventually reach the olfactory epithelium. This part of the nose has a vast amount of receptor neurons which are each covered in hairs called cilia. These cilia trap the scent and send a message to the brain which enables a person to recognise the perfume. The ability to smell immediately has a positive impact. This is important as some research has shown that people without a sense of smell have a less happy life than those who can smell; scents trigger emotions and affect our mood. As a result of this finding, perfume has become as much a science as it has an accessory. Aromatherapy studies the effects of natural botanical perfume ingredients, usually in the form of oils in their purest state. Its looks at the effects upon mood and general well being, and applies the knowledge by improving the perfume in the environment and offering a variety of aromatherapy services aimed at improving people`s lives. Aromacology applies this same approach to any available scent, from flowers to sand, and the findings are currently assisting perfume manufacturers worldwide. The ingredients used in perfume may improve your concentration and enhance your mood. There is a long list of scents that are said to trigger this stimulating effect. Perfumes that contain ingredients such as ginger, sandalwood and rose are claimed by aromatherapists and aromacologists alike to have a stimulating effect on brain neurons. The increased stimulation aided by the use of perfume assists in many everyday tasks, from more focused studying to extra stamina and energy, balanced weight loss to an improved immune system. Another benefit to be gained from wearing perfume is that it can relax your mood. Certain scents have aldehydes which have a calming effect on the brain. The perfume oils which have this effect include eucalyptus and citronella. Other scents can act as a form of sedative, aiding restful sleep, which helps reduce anxiety and tension which in turn creates a wealth of health benefits. The most famous of these perfumes include lavender and bergamot, which have been used for this purpose for centuries and in a variety of countries worldwide. The benefits of perfume are not just highlighted by scientific study. Many psychologists state that humans begin to store information about scents when only a few months old, and that scents affect reactions to people and events more than any of the other senses at this young age. In fact, our taste in smells remains more or less the same whereas tastes influenced by other senses are extremely changeable. This means that we choose perfumes for a reason, either it triggers a feeling of nostalgia or makes us feel a certain way. The perfume chosen also has a social relevance; it tells people something about the wearer, and helps cement their identity. Attraction to another person is influenced by invisible scents known as pheromones, and perfume adds to this. Above all, perfume makes the wearer feel fresh, attractive and more confident; and confidence is a definite benefit. This article is under GNU FDL license and can be distributed without any previous authorization from the author. However the author's name and all the URLs (links) mentioned in the article and biography must be kept.
Health Tips For Better Health
By: Francis Adam
1. Maintain a low-stress lifestyle. Our bodies were not designed for constant high stress levels. Pray your way out of a high-stress lifestyle. If you get everything else right but still have too much stress - it can destroy your health. Let the peace of God rule in your heart! (If it steals your peace - get rid of it!)2. Eat close to the original diet - Gen. 1:29 - which is fresh raw fruit, vegetables, nuts & seeds. Plenty of green leafy (no iceberg lettuce) - daily. The higher the percentage of raw produce, the stronger the immune system. Target 60-85%.3. Drink pure water. Consume about half your weight in ounces daily (120 pound person drinks 60 ounces).4. To reduce your risk of heart disease, cancer and diabetes, minimize or eliminate: meat, dairy, refined grains, salt and sugar/sugar substitutes. Avoid unclean meats (pork, shellfish, catfish, etc.). When eating meat, choose meat which has been raised in a natural free-roaming environment with a natural diet (i.e. grass-only fed beef) and raised/processed without hormones, antibiotics or chemicals. Use meat more as a condiment instead of main course.5. Minimize or eliminate stimulants. The most common stimulants are nicotine, caffeine, drugs, salt & sugar. Some herbs are stimulants and for temporary use only.6. The two most important supplements are: (a) The (8 essential) glyconutrients which cause proper cell-to-cell communication. When the cells communicate properly, they send the healing message along with ‘proper functioning’ messages. No other supplement does for the health of the body what the glyconutrients do and they are not found in our diets today in quantities needed. And, (b) friendly bacteria/probiotics. The average colon flora is 80% bad bacteria/20% good and should be 80% good bacteria/20% bad. Very important for improved health.7. Guard your environment. Avoid man-made chemicals (on skin, in air you breath, in foods/drinks you consume and on clothing). Get fresh air and sunshine daily. Deliberately oxygenate your body daily. Cancer can’t live in oxygenated cells.8. Consume fats in the form of raw, unheated, non-hydrogenated vegetable fats - raw nuts & seeds, avocados, coconut, extra virgin olive oil (most other oils have been heated in processing) and fresh ground flax seed daily. Avoid animal fat, hydrogenated fat and heated fat.9. Eat with the right attitude! Chew your food until it turns to liquid, in a relaxed environment. Eat when hungry but do not idolize food or use it for comfort. Jesus is our comfort - The Living Well. And let Him help you with forgiveness. Forgiveness directly affects our health. Just let it go!10. Maximize ‘stop and go’! Get plenty of sleep (7-8 hours per day minimum) and exercise regularly - walking, trampoline rebounding, video workouts, etc. Variety is the key to making exercise easier!
1. Maintain a low-stress lifestyle. Our bodies were not designed for constant high stress levels. Pray your way out of a high-stress lifestyle. If you get everything else right but still have too much stress - it can destroy your health. Let the peace of God rule in your heart! (If it steals your peace - get rid of it!)2. Eat close to the original diet - Gen. 1:29 - which is fresh raw fruit, vegetables, nuts & seeds. Plenty of green leafy (no iceberg lettuce) - daily. The higher the percentage of raw produce, the stronger the immune system. Target 60-85%.3. Drink pure water. Consume about half your weight in ounces daily (120 pound person drinks 60 ounces).4. To reduce your risk of heart disease, cancer and diabetes, minimize or eliminate: meat, dairy, refined grains, salt and sugar/sugar substitutes. Avoid unclean meats (pork, shellfish, catfish, etc.). When eating meat, choose meat which has been raised in a natural free-roaming environment with a natural diet (i.e. grass-only fed beef) and raised/processed without hormones, antibiotics or chemicals. Use meat more as a condiment instead of main course.5. Minimize or eliminate stimulants. The most common stimulants are nicotine, caffeine, drugs, salt & sugar. Some herbs are stimulants and for temporary use only.6. The two most important supplements are: (a) The (8 essential) glyconutrients which cause proper cell-to-cell communication. When the cells communicate properly, they send the healing message along with ‘proper functioning’ messages. No other supplement does for the health of the body what the glyconutrients do and they are not found in our diets today in quantities needed. And, (b) friendly bacteria/probiotics. The average colon flora is 80% bad bacteria/20% good and should be 80% good bacteria/20% bad. Very important for improved health.7. Guard your environment. Avoid man-made chemicals (on skin, in air you breath, in foods/drinks you consume and on clothing). Get fresh air and sunshine daily. Deliberately oxygenate your body daily. Cancer can’t live in oxygenated cells.8. Consume fats in the form of raw, unheated, non-hydrogenated vegetable fats - raw nuts & seeds, avocados, coconut, extra virgin olive oil (most other oils have been heated in processing) and fresh ground flax seed daily. Avoid animal fat, hydrogenated fat and heated fat.9. Eat with the right attitude! Chew your food until it turns to liquid, in a relaxed environment. Eat when hungry but do not idolize food or use it for comfort. Jesus is our comfort - The Living Well. And let Him help you with forgiveness. Forgiveness directly affects our health. Just let it go!10. Maximize ‘stop and go’! Get plenty of sleep (7-8 hours per day minimum) and exercise regularly - walking, trampoline rebounding, video workouts, etc. Variety is the key to making exercise easier!
Dieting for Fertility
By: Li Ming Wong
Obesity has many negative health consequences. Some are better known and documented than others. Recent studies have shown that yet another potential consequence of obesity is difficulty when it comes to conceiving a baby. Fertility troubles are a growing problem in this country and around the world. One reason that is being hailed as a very viable culprit is obesity. While most people look immediately to the female in the relationship for this particular problem the facts indicate that male obesity can also lead to a low sperm count, which can also hamper fertility efforts and progress.Our bodies were designed for specific purposes. It is utterly amazing how well each part of the human body works to support the others. There are very few machines that can compete with the genius of the design of the human body. After thousands of years to study the human body there are still many mysteries hidden within. The truth comes down to this however, we put things into our bodies, and abuse our bodies in ways that our bodies were simply not designed to take and yet we still manage to adapt and survive many of these things.It's amazing when you think about that the human body endures the many things it does without permanent and irrevocable damage. The good news for those attempting to conceive is that the human body also has the remarkable ability to heal itself. This means that those who find their efforts to conceive have been hampered by obesity have also seen positive changes by losing as little as five to ten percent of your ability to conceive.If both partners are overweight then it might be a good idea to work together to shed those unwanted pounds and adopt a healthier, more active lifestyle. Being active when trying to conceive and throughout the pregnancy is a good idea for the female in the relationship at any rate as this can help in the process of labor and delivery.If you are trying to conceive without success and have been doing so for more than a year it is probably in your best interest to seek the services of a fertility specialist in order to rule out other possible considerations. Though it is rarely a bad idea to adopt a healthier lifestyle you should also consult your doctor before beginning a strict diet or weight loss regimen in order to make sure there aren't other factors that may be causing your weight issues. This is particularly true if you have gained a good deal of weight in a rather short amount of time. In addition to conception difficulty obesity can also lead to a greater risk of miscarriage once conception has occurred. Obesity also leads to a greater risk of conditions such as gestational diabetes during the pregnancy, pre-eclampsia, and in some cases still birth and birth defects. It is no small hindrance to a healthy pregnancy and should be carefully considered before attempting to conceive. Another consideration when it comes to obesity and fertility is that being overweight can also hamper the affects of fertility treatments. This means that the process is typically lengthier and will cost significantly more over time than if obesity were not a factor. When coupled with the risks to the baby this is something that should not be taken lightly when making plans for fertility treatments. If your BMI is greater than 30 there are many fertility clinics that simply will not offer their services. Some limit it to greater than 35 and others 40. If you feel that fertility treatments are the only course of action available to you and your BMI is greater than 30, the first suggestion you are likely to hear is the suggestion that you make serious weight loss efforts and lifestyle changes before proceeding. You may find that once you begin to shed the pounds, fertility intervention is no longer necessary.
Obesity has many negative health consequences. Some are better known and documented than others. Recent studies have shown that yet another potential consequence of obesity is difficulty when it comes to conceiving a baby. Fertility troubles are a growing problem in this country and around the world. One reason that is being hailed as a very viable culprit is obesity. While most people look immediately to the female in the relationship for this particular problem the facts indicate that male obesity can also lead to a low sperm count, which can also hamper fertility efforts and progress.Our bodies were designed for specific purposes. It is utterly amazing how well each part of the human body works to support the others. There are very few machines that can compete with the genius of the design of the human body. After thousands of years to study the human body there are still many mysteries hidden within. The truth comes down to this however, we put things into our bodies, and abuse our bodies in ways that our bodies were simply not designed to take and yet we still manage to adapt and survive many of these things.It's amazing when you think about that the human body endures the many things it does without permanent and irrevocable damage. The good news for those attempting to conceive is that the human body also has the remarkable ability to heal itself. This means that those who find their efforts to conceive have been hampered by obesity have also seen positive changes by losing as little as five to ten percent of your ability to conceive.If both partners are overweight then it might be a good idea to work together to shed those unwanted pounds and adopt a healthier, more active lifestyle. Being active when trying to conceive and throughout the pregnancy is a good idea for the female in the relationship at any rate as this can help in the process of labor and delivery.If you are trying to conceive without success and have been doing so for more than a year it is probably in your best interest to seek the services of a fertility specialist in order to rule out other possible considerations. Though it is rarely a bad idea to adopt a healthier lifestyle you should also consult your doctor before beginning a strict diet or weight loss regimen in order to make sure there aren't other factors that may be causing your weight issues. This is particularly true if you have gained a good deal of weight in a rather short amount of time. In addition to conception difficulty obesity can also lead to a greater risk of miscarriage once conception has occurred. Obesity also leads to a greater risk of conditions such as gestational diabetes during the pregnancy, pre-eclampsia, and in some cases still birth and birth defects. It is no small hindrance to a healthy pregnancy and should be carefully considered before attempting to conceive. Another consideration when it comes to obesity and fertility is that being overweight can also hamper the affects of fertility treatments. This means that the process is typically lengthier and will cost significantly more over time than if obesity were not a factor. When coupled with the risks to the baby this is something that should not be taken lightly when making plans for fertility treatments. If your BMI is greater than 30 there are many fertility clinics that simply will not offer their services. Some limit it to greater than 35 and others 40. If you feel that fertility treatments are the only course of action available to you and your BMI is greater than 30, the first suggestion you are likely to hear is the suggestion that you make serious weight loss efforts and lifestyle changes before proceeding. You may find that once you begin to shed the pounds, fertility intervention is no longer necessary.
Effective Patient Reported Outcomes
By: Elida Ramberge
IntroductionReliable patient reports in clinical research have been a long sought-after goal. In response to the increasing focus on these reports in clinical trials the Food and Drug Administration (FDA) issued its "Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" (Guidance) in February 2006, which began the dialogue regarding standards for these reports. The Guidance serves as a description of how the FDA evaluates the effectiveness of a Patient Reported Outcome (PRO) in collection of clinical trial endpoint data. Laurie Burke provides the FDA's views on PROs: The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined, says Laurie Burke, R.Ph., M.P.H., director of the FDA's study endpoints and label development team in the Office of New Drugs. "It's all about the patients."Definition of A Patient Reported OutcomeIt is useful to briefly review what constitutes a PRO before examining how the guidance document influences the design, deployment and implementation of processes that aim to collect information directly from participants in clinical research. PRO instruments run the gamut from discrete inquiry, e.g., pain, to domains of functioning, e.g., physical, psychological or social. In its most fundamental form a PRO is the patient's measurement/assessment of health status free of the interpretation by anyone else, including physicians and clinicians. It is generally accepted that PROs are desirable when the endpoint being examined is known only to the patient; when the patient's perspective of treatment effectiveness may be unique; and when the assessment format is more reliable when administered more formally. "The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels," says Robert Temple, MD director of the Food and Drug Administration's Office of Medical Policy.How PRO's Differ From Other Clinical AssessmentsAs the best source of information about how he or she feels, the patient's role in the conduct of the study shifts the importance of some assessments from the physician or clinician to the patient. This shift represents a role transformation that recognizes the value of patient reports, which transformation is sometimes not readily embraced by physicians or clinical staff. The difficulty comprehending the shift was exemplified during a recent Kronos HelpDesk call when a study coordinator asked how it could be possible that a patient was able to assess their disease state. The question was not born of a disdain for the patient's ability to assess their disease, but rather a lack of education about how the patients role in the study as the authority on primary endpoint data. The Guidance makes scant mention of the education necessary for patients who are being asked to record the most important data in the study - endpoint data. Unlike the expectation that clinical site training include a review of Good Clinical Practices, patients do not receive similar training. Training commensurate with the task of diary/outcome data entry is necessary to ensure the validity of the data being entered by patients. Herein lies the impetus for this discussion. Although the Guidance notes its purpose as explanation of "how the FDA evaluates such instruments for their usefulness in measuring and characterizing the benefit of medical product treatment" the shift in the respective roles of the patient and the physician or clinician does not receive the attention by way of elaboration or guidance necessary to ensure the validity of data being recorded. Beyond recommending that "Sponsors should consider the method of data collection …associated with instrument administration, including instructions to interviewers, instructions for self-administration, instructions for supervising self-administration, case report forms or examples of electronic PRO instrument,.." the Guidance lacks the specificity for administration procedures necessary to engage patients as integral to study conduct. Anecdotal information derived from this clinician's experience has demonstrated that implementation processes/procedures have a direct affect on how a PRO is administered. The example offered involves the administration of the SASSI (Substance Abuse Subtle Screening Inventory). The inherent nature of a behavioral health PRO of experience/assessment makes this PRO most dependent on patient reports with the least objective endpoint data to support claims. During administration of the SASSI, patients inquired about the verbiage of questions. The validity of the results depended on the administrator's understanding that adding information by way of explaining the question invalidated the response because the subject was no longer responding to the question - the patient would have been responding to the question as interpreted by the administrator. Reliability of data is affected by variability in administration, however, the Guidance does not offer recommendations to minimize this effect. Recommended Additions to the Guidance1.Lay out in greater detail how the role shift affects implementation of the studya. Engage patients as participants in study conduct - explain what the study hopes to accomplishb. Educate patients in the importance of their role and the data they enter to the study's outcome c. Elaborate on how they will fulfill the expectation of recording their datad. Recommend reviewing instrument in detaile. Provide audio-visual aide that reaffirms process discussed2. Elaborate on the education necessary to demonstrate to the Investigational Site and the patient their respective roles in the study3. Provide off-site support for patients who need assistance complying with the requirements to report outcomesIt is this clinician's experience that patients are anxious to comply with their responsibility in a clinical trial, even though they are sometimes forgetful when completing diaries or other outcome instruments. Electronic data capture reminders that are built-in, provide patients with the necessary tools to meet their responsibility. It behooves the clinical research community to provide these tools as the return will be better data as patients engage in a more thoughtful process when entering information about their experience during a clinical study. ABOUT KRONOS COMMUNICATED DATA: Since 1993, Kronos has provided outstanding professional services and products for clinical research. Specializing in the innovative, electronic data capture of patients' and subjects' feedback in studies, the experienced staff at Kronos has been key to the success of many over the years. It is also an SBA Certified Woman-Owned-Business which is helpful when government funding is being used. For information matching your study requirements, contact KCDI at 888-538-1690 or kronos@kronosdata.com
IntroductionReliable patient reports in clinical research have been a long sought-after goal. In response to the increasing focus on these reports in clinical trials the Food and Drug Administration (FDA) issued its "Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" (Guidance) in February 2006, which began the dialogue regarding standards for these reports. The Guidance serves as a description of how the FDA evaluates the effectiveness of a Patient Reported Outcome (PRO) in collection of clinical trial endpoint data. Laurie Burke provides the FDA's views on PROs: The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined, says Laurie Burke, R.Ph., M.P.H., director of the FDA's study endpoints and label development team in the Office of New Drugs. "It's all about the patients."Definition of A Patient Reported OutcomeIt is useful to briefly review what constitutes a PRO before examining how the guidance document influences the design, deployment and implementation of processes that aim to collect information directly from participants in clinical research. PRO instruments run the gamut from discrete inquiry, e.g., pain, to domains of functioning, e.g., physical, psychological or social. In its most fundamental form a PRO is the patient's measurement/assessment of health status free of the interpretation by anyone else, including physicians and clinicians. It is generally accepted that PROs are desirable when the endpoint being examined is known only to the patient; when the patient's perspective of treatment effectiveness may be unique; and when the assessment format is more reliable when administered more formally. "The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels," says Robert Temple, MD director of the Food and Drug Administration's Office of Medical Policy.How PRO's Differ From Other Clinical AssessmentsAs the best source of information about how he or she feels, the patient's role in the conduct of the study shifts the importance of some assessments from the physician or clinician to the patient. This shift represents a role transformation that recognizes the value of patient reports, which transformation is sometimes not readily embraced by physicians or clinical staff. The difficulty comprehending the shift was exemplified during a recent Kronos HelpDesk call when a study coordinator asked how it could be possible that a patient was able to assess their disease state. The question was not born of a disdain for the patient's ability to assess their disease, but rather a lack of education about how the patients role in the study as the authority on primary endpoint data. The Guidance makes scant mention of the education necessary for patients who are being asked to record the most important data in the study - endpoint data. Unlike the expectation that clinical site training include a review of Good Clinical Practices, patients do not receive similar training. Training commensurate with the task of diary/outcome data entry is necessary to ensure the validity of the data being entered by patients. Herein lies the impetus for this discussion. Although the Guidance notes its purpose as explanation of "how the FDA evaluates such instruments for their usefulness in measuring and characterizing the benefit of medical product treatment" the shift in the respective roles of the patient and the physician or clinician does not receive the attention by way of elaboration or guidance necessary to ensure the validity of data being recorded. Beyond recommending that "Sponsors should consider the method of data collection …associated with instrument administration, including instructions to interviewers, instructions for self-administration, instructions for supervising self-administration, case report forms or examples of electronic PRO instrument,.." the Guidance lacks the specificity for administration procedures necessary to engage patients as integral to study conduct. Anecdotal information derived from this clinician's experience has demonstrated that implementation processes/procedures have a direct affect on how a PRO is administered. The example offered involves the administration of the SASSI (Substance Abuse Subtle Screening Inventory). The inherent nature of a behavioral health PRO of experience/assessment makes this PRO most dependent on patient reports with the least objective endpoint data to support claims. During administration of the SASSI, patients inquired about the verbiage of questions. The validity of the results depended on the administrator's understanding that adding information by way of explaining the question invalidated the response because the subject was no longer responding to the question - the patient would have been responding to the question as interpreted by the administrator. Reliability of data is affected by variability in administration, however, the Guidance does not offer recommendations to minimize this effect. Recommended Additions to the Guidance1.Lay out in greater detail how the role shift affects implementation of the studya. Engage patients as participants in study conduct - explain what the study hopes to accomplishb. Educate patients in the importance of their role and the data they enter to the study's outcome c. Elaborate on how they will fulfill the expectation of recording their datad. Recommend reviewing instrument in detaile. Provide audio-visual aide that reaffirms process discussed2. Elaborate on the education necessary to demonstrate to the Investigational Site and the patient their respective roles in the study3. Provide off-site support for patients who need assistance complying with the requirements to report outcomesIt is this clinician's experience that patients are anxious to comply with their responsibility in a clinical trial, even though they are sometimes forgetful when completing diaries or other outcome instruments. Electronic data capture reminders that are built-in, provide patients with the necessary tools to meet their responsibility. It behooves the clinical research community to provide these tools as the return will be better data as patients engage in a more thoughtful process when entering information about their experience during a clinical study. ABOUT KRONOS COMMUNICATED DATA: Since 1993, Kronos has provided outstanding professional services and products for clinical research. Specializing in the innovative, electronic data capture of patients' and subjects' feedback in studies, the experienced staff at Kronos has been key to the success of many over the years. It is also an SBA Certified Woman-Owned-Business which is helpful when government funding is being used. For information matching your study requirements, contact KCDI at 888-538-1690 or kronos@kronosdata.com
Body Care: Start in the Shower
By: Francis Adam
It is important to have a body care routine. When body care products are not used on a regular basis, they are ineffective. Nobody can expect smooth skin from a single day of moisturizing. It takes several days to witness results. In order to maintain that same level, it must be performed routinely. This may seem like a lot of work, but when someone gets into a regular body care regimen, she can manage to do it all in mere minutes!Body Care: Start in the ShowerStart from the top and work down from there. The first thing people should see is a healthy, glowing face. This starts with a good face wash. A foaming face wash is an excellent choice. It is made just for the face and will help retain the skin's moisture. Regular bar soap is not a good idea because it can dry out the face's delicate skin.The next step is to use a good exfoliator. This should be gentle enough for the face but may also be used on every part of the body. An exfoliator removes the dead, dry top layer of skin cells and reveals the healthy skin underneath. This should not be done every day, but should be done at least once a week.While in the shower, it is best to use a shower gel to wash the body. This is more delicate than a bar soap and also smells wonderful. It is especially easy when used in combination with a loofah. A loofah helps to exfoliate skin as well.Body Care: Out of the ShowerAfter stepping out of the shower, the first thing to do is apply moisturizer to the entire face and body. This generally requires two different products since the face will need something gentler. This is the best time to apply a moisturizer because damp skin absorbs more effectively than dry skin. This will help keep the skin soft and smooth.There are special moisturizers that are made for hands and feet. Feet are often neglected when it comes to total body care. These moisturizers are made especially for rougher, drier skin. Our feet and hands are exposed to so much that they need something a little stronger to keep them looking and feeling healthy and beautiful.Body Care: During the DayIt is essential that people are aware of their bodies all day long. It is a good idea to carry antibacterial hand lotion or soap. There are germs everywhere and not enough places to wash our hands. This will help keep the hands and face germ free since everyone touches their face during the day. It is also a good idea to carry wipes that absorb face moisture. This will help keep pores from becoming clogged and also feels great on the skin.Body Care: Before BedBefore going to bed each night, there are several body care products to use in order to maintain healthy skin. The first is a good cosmetics remover. It is not recommended that a woman retire for the evening without removing her make-up, as it tends to clog pores and cause breakouts. Once this is accomplished, the face should be washed with a good foaming cleanser. After washing the face, it is a good idea to use a toner. A toner will clean out the pores of the face, reaching deeper than the foaming cleanser can. Finally, apply a blemish cream that will work overnight. This entire routine should take only five minutes and is worth every second to have beautiful skin!Body care is essential all day long. In order to have skin look and feel its best, it is important to follow each of these steps. Following a body care regimen every day will keep skin beautiful and soft!
It is important to have a body care routine. When body care products are not used on a regular basis, they are ineffective. Nobody can expect smooth skin from a single day of moisturizing. It takes several days to witness results. In order to maintain that same level, it must be performed routinely. This may seem like a lot of work, but when someone gets into a regular body care regimen, she can manage to do it all in mere minutes!Body Care: Start in the ShowerStart from the top and work down from there. The first thing people should see is a healthy, glowing face. This starts with a good face wash. A foaming face wash is an excellent choice. It is made just for the face and will help retain the skin's moisture. Regular bar soap is not a good idea because it can dry out the face's delicate skin.The next step is to use a good exfoliator. This should be gentle enough for the face but may also be used on every part of the body. An exfoliator removes the dead, dry top layer of skin cells and reveals the healthy skin underneath. This should not be done every day, but should be done at least once a week.While in the shower, it is best to use a shower gel to wash the body. This is more delicate than a bar soap and also smells wonderful. It is especially easy when used in combination with a loofah. A loofah helps to exfoliate skin as well.Body Care: Out of the ShowerAfter stepping out of the shower, the first thing to do is apply moisturizer to the entire face and body. This generally requires two different products since the face will need something gentler. This is the best time to apply a moisturizer because damp skin absorbs more effectively than dry skin. This will help keep the skin soft and smooth.There are special moisturizers that are made for hands and feet. Feet are often neglected when it comes to total body care. These moisturizers are made especially for rougher, drier skin. Our feet and hands are exposed to so much that they need something a little stronger to keep them looking and feeling healthy and beautiful.Body Care: During the DayIt is essential that people are aware of their bodies all day long. It is a good idea to carry antibacterial hand lotion or soap. There are germs everywhere and not enough places to wash our hands. This will help keep the hands and face germ free since everyone touches their face during the day. It is also a good idea to carry wipes that absorb face moisture. This will help keep pores from becoming clogged and also feels great on the skin.Body Care: Before BedBefore going to bed each night, there are several body care products to use in order to maintain healthy skin. The first is a good cosmetics remover. It is not recommended that a woman retire for the evening without removing her make-up, as it tends to clog pores and cause breakouts. Once this is accomplished, the face should be washed with a good foaming cleanser. After washing the face, it is a good idea to use a toner. A toner will clean out the pores of the face, reaching deeper than the foaming cleanser can. Finally, apply a blemish cream that will work overnight. This entire routine should take only five minutes and is worth every second to have beautiful skin!Body care is essential all day long. In order to have skin look and feel its best, it is important to follow each of these steps. Following a body care regimen every day will keep skin beautiful and soft!
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